Atrial FibrillationNCT03091855
PLUG Dementia Trial and MRI PLUG Dementia Sub-Study
An observational study of Atrial Fibrillation and Dementia, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
PLUG Dementia Trial: Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Dementia, Cognitive Decline
- What is being tested?
- Questionnaire and Magnetic Resonance Imaging
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 8 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study.
Who may be able to join
- Male or female >65 years of age
- Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 6 months of enrollment
- Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2.
- Recipient of a left atrial appendage closure device within 3 months of enrollment (within 6 months, for patients considered for the MRI PLUG Dementia Sub-Study)
- Have the ability to complete a mini-mental status evaluation
- Have the ability to independently comprehend and complete a quality of life and dementia questionnaires.
- Ability to provide informed consent for study participation
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Who cannot join
- Have a history of any form of dementia
- Have a life expectancy less than 24 months
- Are unable to comply with the follow-up schedule
- An upper age limit not to be used if participation inclusion criteria are met.
- Participation in any other clinical trials involving an investigational or marketed drug within 30 days prior to entry in this study;
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
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- The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.
- In addition to the above exclusion criteria, patients considered for the MRI PLUG Dementia Sub-Study will be excluded if the patient -
- Does not receive a left atrial appendage closure device
- Has contraindication towards the MRI scan (presence of a nonconditional cardiac implantable device, a history of metallic implants, shrapnel, neurosurgical clip placement)
- Has conditional cardiac MRI cardiac implantable device, joint replacements, coronary stents, ASD/PFO closure devices, sternal wires or most prosthetic heart valves
- Has severe renal dysfunction, defined as a creatinine clearance <15 mL/min (documented within the last 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overall and MRI-based Impact of Percutaneous Left Atrial Appendage Closure on the Cognitive Decline and Dementia in Patients With Atrial Fibrillation (PLUG Dementia Trial and MRI PLUG Dementia Sub-Study)
PLUG Dementia Trial:
Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. A subset of patients (n=20), will receive a cranial MRI at baseline and 24-month visit.
Read more
MRI PLUG Dementia Sub-Study:
In addition to the above, 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit.
- Conditions
- Atrial Fibrillation, Dementia, Cognitive Decline
- Being tested
- Questionnaire, Magnetic Resonance Imaging
- Medical subject headings
- Atrial Fibrillation, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
Magnetic Resonance ImagingDiagnostic test
MRI at baseline and at 24 months post-enrollment for 20 sub-study participants
| Study group | Role | What they receive |
|---|---|---|
| PLUG Dementia Trial | Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. Receives: Other: Questionnaire | |
| MRI PLUG Dementia Sub-Study | 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia Incidence
Incident dementia determined by a formal diagnosis by a neurologist.
Measured: 24 months
Change in cognitive decline
Moderate cognitive decline defined as a 30% decrease in Alzheimer's Disease Assessment Scale score or those with a score <50% or a 30% change on the Disability Assessment for Dementia.
Measured: 24 months
Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants)
assess the incidence of baseline micro- and macro-cerebral ischemic events (both bleeds and clots) at the time of left atrial appendage closure and compare this with a serial study.
Measured: 24 months
Secondary outcomes (1)
Changes in cranial MRI
Incidence of bleeding and/or clots in the brain.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start3 Apr 2017
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Why it stopped: Terminated due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091855
- Sponsor's protocol ID
- 1050344
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall and MRI-based Impact of Percutaneous Left Atrial Appendage Closure on the Cognitive Decline and Dementia in Patients With Atrial Fibrillation (PLUG Dementia Trial and MRI PLUG Dementia Sub-Study)
- ClinicalTrials.gov ID
- NCT03091855
- Acronym / sponsor ID
- 1050344
- Conditions
- Atrial Fibrillation, Dementia, Cognitive Decline
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PLUG Dementia Trial:
Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. A subset of patients (n=20), will receive a cranial MRI at baseline and 24-month visit.
MRI PLUG Dementia Sub-Study:
In addition to the above, 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLUG Dementia Trial | – | Other: QuestionnairePatients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. |
| MRI PLUG Dementia Sub-Study | – | Diagnostic Test: Magnetic Resonance Imaging20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study.
Key inclusion criteria (8 listed)
- Male or female >65 years of age
- Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 6 months of enrollment
- Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2.
- Recipient of a left atrial appendage closure device within 3 months of enrollment (within 6 months, for patients considered for the MRI PLUG Dementia Sub-Study)
- Have the ability to complete a mini-mental status evaluation
Key exclusion criteria (12 listed)
- Have a history of any form of dementia
- Have a life expectancy less than 24 months
- Are unable to comply with the follow-up schedule
- An upper age limit not to be used if participation inclusion criteria are met.
- Participation in any other clinical trials involving an investigational or marketed drug within 30 days prior to entry in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires | Other | PLUG Dementia Trial |
| Magnetic Resonance ImagingMRI at baseline and at 24 months post-enrollment for 20 sub-study participants | Diagnostic test | MRI PLUG Dementia Sub-Study |
Primary outcome
Dementia Incidence
Time frame: 24 months
Incident dementia determined by a formal diagnosis by a neurologist.
Change in cognitive decline
Time frame: 24 months
Moderate cognitive decline defined as a 30% decrease in Alzheimer's Disease Assessment Scale score or those with a score <50% or a 30% change on the Disability Assessment for Dementia.
Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants)
Time frame: 24 months
assess the incidence of baseline micro- and macro-cerebral ischemic events (both bleeds and clots) at the time of left atrial appendage closure and compare this with a serial study.
1 secondary outcome
Changes in cranial MRI
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Terminated due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Dementia, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia Incidence (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.